510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K921722Substantially Equivalent

Bard(r) Leventhal(tm) Gyne-Flo(tm) Cannula

Bard Reproductive Systems, Tewksbury MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921722 is the FDA 510(k) clearance record for BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA, a class II device, cleared for Bard Reproductive Systems on under FDA product code HET (Laparoscope, Gynecologic (And Accessories)). FDA records list one 510(k) clearance for Bard Reproductive Systems. As of , FDA records show no recalls naming K921722.

Clearance record

Decision date
Received
(753 days to decision)
Product code
HET Laparoscope, Gynecologic (And Accessories)
Regulation
21 CFR 884.1720
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Bard Reproductive Systems 200 Ames Pond Dr., Tewksbury MA
510(k) summary
Summary
Third party review
No

Clearances, product code HET

Trailing 12 months

FDA records hold no clearances under product code HET in the trailing twelve months.

FDA records show no clearances under product code HET in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HET, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260